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FDA 510(k)

InterSpace Knee Extra-Large Size, InterSpace Knee ATS

K-Number: K181732 · 2019-04-27

ApplicantTecres S.P.A.
Decision Date2019-04-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InterSpace Knee Extra-Large Size, InterSpace Knee ATS is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2019-04-27 under 510(k) number K181732. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InterSpace Knee Extra-Large Size, InterSpace Knee ATS?

InterSpace Knee Extra-Large Size, InterSpace Knee ATS is a medical device that received FDA 510(k) clearance on 2019-04-27. The listed applicant is Tecres S.P.A.. The 510(k) number is K181732.

When did InterSpace Knee Extra-Large Size, InterSpace Knee ATS receive FDA 510(k) clearance?

InterSpace Knee Extra-Large Size, InterSpace Knee ATS received FDA 510(k) clearance on 2019-04-27, under 510(k) number K181732.

Who is the listed applicant for InterSpace Knee Extra-Large Size, InterSpace Knee ATS?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InterSpace Knee Extra-Large Size, InterSpace Knee ATS?

The FDA product code for InterSpace Knee Extra-Large Size, InterSpace Knee ATS is JWH.

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Other records listing Tecres S.P.A. as applicant

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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